Job Description

Job Description

Senior Regulatory Affairs Specialist (12-Month Contract)

📍 Location: Open to Remote

📅 Contract Duration: 12 months to start

🎓 Education: Bachelor’s degree required

💼 Experience: Minimum 9 years of relevant regulatory experience

About the Role

We are seeking an experienced Senior Regulatory Affairs Specialist for one of our clients to support global and regional regulatory activities for Class IIa medical devices. This role will be instrumental in driving compliance initiatives, remediating regulatory documentation, and developing regulatory strategies that align with evolving global requirements.

Key Responsibilities

• Assess global, societal, and economic trends, stakeholder concerns, and regulatory developments to shape regulatory strategy.
• Remediate regulatory documentation in accordance with U.S. FDA 510(k) requirements.
• Remediate EU MDR Technical Documentation Files for Class IIa medical devices.
• Develop and update global, regional, and multi-country regulatory strategies, ensuring alignment with organizational objectives.
• Provide guidance on integrating regulatory considerations into product entry and exit strategies.
• Assess market access requirements and potential obstacles (federal, state, reimbursement, purchasing groups, etc.) and develop strategic solutions.
• Evaluate and adapt strategies in response to changing regulatory landscapes.
• Negotiate with regulatory authorities on complex issues throughout the product lifecycle.
• Establish and maintain working relationships with government and non-government stakeholders affecting market access and distribution.
• Identify the need for and lead the creation and implementation of new regulatory procedures and standard operating procedures (SOPs).
• Develop and manage training programs to educate stakeholders on regulatory requirements and ensure organization-wide compliance.
• Assess product and clinical safety risks during clinical phases and recommend regulatory solutions.
• Evaluate preclinical, clinical, and manufacturing changes for regulatory impact and propose appropriate filing strategies.
• Review and assess regulatory submissions and clinical plans for compliance and alignment with business goals.
• Provide regulatory guidance on product claims and labeling strategies.
• Ensure clinical and nonclinical data support proposed product claims and meet regulatory expectations.
• Prepare cross-functional teams for interactions with regulatory authorities, including advisory and panel meetings.

Qualifications

• Bachelor’s degree required (advanced degree preferred).
• Minimum 9 years of experience in regulatory affairs within the medical device industry.
• Proven experience with FDA 510(k) submissions and EU MDR compliance .
• Strong understanding of global regulatory frameworks and medical device lifecycle management.
• Exceptional communication, negotiation, and strategic planning skills.

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